| Date |
Drug/Device |
Alert |
| 1.11.12 |
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory—Potential Safety Risk |
ALERT |
| 1.5.12 |
ShoulderFlex Massager: Warning-Risk of Strangulation |
DEVICE CAUTIONARY NOTICE |
| 12.21.11 |
Lioresal (baclofen) intrathecal: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 12.21.11 |
Dilantin (phenytoin): Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 12.14.11 |
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events |
DRUG CAUTIONARY NOTICE |
| 11.10.11 |
Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury |
ALERT |
| 10.17.11 |
Cymbalta (duloxetine hydrochloride): Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 10.17.11 |
FDA Safety Communication: Preventing Surgical Fires |
WARNING |
| 9.20.11 |
Zofran (ondansetron): Drug Safety Communication ‐ Risk of Abnormal Heart Rhythms |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Mobic (meloxicam) Tablets and Oral Suspension:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Neurontin (gabapentin) Capsules, Tablets and Oral Solution: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Celexa (citalopram hydrobromide) Tablets and Oral Solution: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.12.11 |
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class 1 Recall |
DEVICE CAUTIONARY NOTICE |
| 9.12.11 |
Tumor Necrosis Factor‐alpha (TNFα) Blockers: Label Change ‐ Boxed Warning Updated for Risk of Infection from Legionella and Listeria |
DRUG CAUTIONARY NOTICE |
| 9.7.11 |
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment |
DRUG CAUTIONARY NOTICE |
| 8.31.11 |
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing |
DRUG CAUTIONARY NOTICE |
| 8.30.11 |
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses |
DRUG WARNING |
| 8.9.11 |
Methylene Blue
Drug Safety Communication ‐ Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications |
DRUG WARNING |
| 8.9.11 |
Zyvox (linezolid)
Drug Safety Communication ‐ Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications |
DRUG WARNING |
| 7.29.11 |
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide) tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Feraheme (ferumoxytol) Injection: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Ditropan XL (oxybutynin chloride) tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Benicar (olmesartan medoxomil) Tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Zocor (simvastatin) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Zmax (azithromycin extended release) for oral suspension: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Vytorin (ezetimibe/simvastatin) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Simcor (niacin extended‐release/simvastatin) tablets:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Prilosec (omeprazole) Delayed‐Release Capsules, Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Pepcid (famotidine) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Nexium (esomeprazole magnesium) for delayed‐release oral suspension, delayedrelease capsules and (esomeprazole sodium) for injection: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Multaq (dronedarone hydrochloride) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Diovan HCT (valsartan/hydrochlorothiazide) and
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Diovan (valsartan) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Corgard (nadolol) tablets and Corzide (nadolol and bendroflumethiazide) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Avalide (irbesartan/hydrochlorothiazide) tablets:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets: abeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.26.11 |
Chantix (varenicline): Label Change ‐ Risk of Certain Cardiovascular Adverse Events |
DRUG CAUTIONARY NOTICE |
| 7.21.11 |
Oral Osteoporosis Drugs (bisphosphonates): Drug Communication – Potential Increased Risk of Esophageal Cancer |
DRUG CAUTIONARY NOTICE |
| 7.20.11 |
Multaq (dronedarone): Drug Safety Communication ‐
Increased Risk of Death or Serious Cardiovascular Events |
DRUG WARNING |
| 6.30.11 |
Tylenol Extra Strength Caplets, 225 count bottles:
Recall - Uncharacteristic Odor |
DRUG CAUTIONARY NOTICE |
| 6.27.11 |
Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ): Recall - Some Bottles Contain Different St |
DRUG WARNING |
| 6.27.11 |
Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall ‐ Bottle Mislabeled |
DRUG CAUTIONARY NOTICE |
| 6.24.11 |
Erythropoiesis‐Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication ‐ Modified Dosing Recommendations |
DRUG WARNING |
| 6.21.11 |
Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events |
DRUG NOTICE |
| 5.3.11 |
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency |
DRUG CAUTIONARY NOTICE |
| 4.20.11 |
Neurontin (gabapentin) Capsules, Tablets and Oral Solution: Adverse Reactions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 4.20.11 |
Lioresal (baclofen) intrathecal: Warnings and Precautions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
American Regent Initiates Voluntary Nationwide Recall of
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
Flector Patch (diclofenac epolamine topical patch):
Contraindications – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
Voltaren (diclofenac sodium enteric-coated) Tablets
Voltaren-XR (diclofenac sodium extended release) Tablets Cataflam (diclofenac potassium immediate-release) Tablets: Precautions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.4.11 |
FDA Communication: Update on Serious Complications Associated with Negative Wound Pressure Therapy Systems |
DRUG CAUTIONARY NOTICE |
| 3.4.11 |
Expansion of Voluntary Nationwide Recall – Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin |
DRUG CAUTIONARY NOTICE |
| 2.18.11 |
Warfarin Sodium Tablets (Jantoven), 3mg Recall - Mislabeled Bottles Containing Higher Dosage |
DRUG CAUTIONARY NOTICE |
| 2.18.11 |
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall |
DEVICE CAUTIONARY NOTICE |
| 2.7.11 |
Hydrocodone Bitartrate and Acetaminophen Tablets,
Phenobarbital Tablets by Qualitest: Recall – Incorrect Package Labeling |
DRUG NOTICE |
| 1.18.11 |
Remicade (infliximab) for Intravenous (IV) Injection:
Warnings and Adverse Reactions – Labeling Changes |
DRUG WARNING |
| 1.17.11 |
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication |
DRUG WARNING |
| 1.11.11 |
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error – Reports of Accidental Overdose |
DRUG WARNING |
| 12.10.10 |
Dexamethasone Sodium Phosphate Injection, 4mg/mL, 30 mL Multiple Dose Vial: Recall Due to Particulates in Product |
DRUG CAUTIONARY NOTICE |
| 12.10.10 |
Drug Safety Labeling Changes -
Rozerem (Ramelteon) Tablets |
DRUG CAUTIONARY NOTICE |
| 12.10.10 |
Drug Safety Labeling Changes - OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets |
DRUG CAUTIONARY NOTICE |
| 11.19.20 |
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity
Sold as Darvon, Darvocet, and generics |
DRUG WARNING |
| 11.08.10 |
Heparin Sodium (B. Braun): Recall ‐ Trace Contaminant |
DRUG CAUTIONARY NOTICE |
| 10.25.10 |
Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified |
DRUG CAUTIONARY NOTICE |
| 10.20.10 |
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility |
DRUG CAUTIONARY NOTICE |
| 10.19.10 |
Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update |
DRUG CAUTIONARY NOTICE |
| 9.30.10 |
Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials |
DRUG CAUTIONARY NOTICE |
| 9.22.10 |
Drug Safety Labeling Changes - Heparin Sodium in Dextrose injection and in Sodium Chloride injection |
DRUG CAUTIONARY NOTICE |
| 9.13.10 |
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis |
DRUG WARNING |
| 7.21.10 |
Coumadin 1 mg Tablet Blister Packs Recall |
DRUG ALERT |
| 7.21.10 |
Air- or Gas-Pressurized Spray Devices - Risk of Air or Gas Embolism |
DEVICE CAUTIONARY NOTICE |
| 7.21.10 |
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury |
DRUG WARNING |
| 6.07.10 |
Intravenous Medications Manufactured by Claris:
Recall Due to Contamination of Products |
DRUG WARNING |
| 5.26.10 |
Drug Safety Labeling Changes ‐ Proton Pump Inhibitors (PPI) |
DRUG CAUTIONARY NOTICE |
| 5.25.10 |
Drug Safety Labeling Changes ‐ Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen) |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Zonegran (zonisamide) capsules |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Tisseel (fibrin sealant) |
DRUG CAUTIONARY NOTICE |
| 5.14.10 |
Class I Recall: GE Healthcare Aisys and Avance Anesthesia Systems |
DEVICE WARNING |
| 5.06.10 |
Baxter Colleague Infusion Pumps: FDA Ordering Recall |
DEVICE CAUTIONARY NOTICE |
| 5.06.10 |
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Boniva (ibandronate sodium) tablets |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Coumadin (warfarin sodium) tablets and injection |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Kenalog (triamcinolone acetonide) injectable suspension |
DRUG CAUTIONARY NOTICE |
| 2.19.10 |
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp Drug Safety Communication |
DRUG CAUTIONARY NOTICE |
| 1.21.10 |
McNeil Consumer Healthcare OTC products:
Recall – 12/09 recall of Tylenol arthritis caplets now expanded to multiple other products |
DRUG CAUTIONARY NOTICE |
| 1.06.10 |
Thermoflect Blankets and product line –
Recall: Products are not to be used in MR environment |
DEVICE CAUTIONARY NOTICE |
| 1.06.10 |
Tylenol Arthritis Pain Caplet 100 count: Recall of all lots due to reports of odor associated with nausea, vomiting and diarrhea |
DRUG CAUTIONARY NOTICE |
| 12.22.09 |
Drug Safety Labeling Changes – Actiq (fentanyl citrate) oral transmucosal |
DRUG WARNING |
| 12.22.09 |
Drug Safety Labeling Changes – Qualaquin (quinine sulfate) 324 mg capsules |
DRUG WARNING |
| 12.10.09 |
Norpramin (desipramine hydrochloride) –
Risk of Sudden Death and Cardiac Dysrhythmias |
DRUG WARNING |
| 12.10.09 |
Voltaren Gel (diclofenac sodium topical gel) –
Hepatic Effects Labeling Change: Cases of Drug |
DRUG WARNING |
| 12.10.09 |
Steris System 1 Processor: FDA Notice and Recommendations-Unapproved Device With Potential for Improper Sterilization and Disinfection |
DEVICE CAUTIONARY NOTICE |
| 12.03.09 |
Stryker Operating Room System II Surgical Navigation System: Recall due to potential for the navigation PC SPC-1 component to stop working |
DEVICE WARNING |
| 11.07.09 |
Synthes Synex II Central Body Components ‐‐
Class I Recall Due to Potential for Hazard to Patients |
DEVICE ALERT - CLASS I RECALL |
| 10.30.09 |
Drug Safety Labeling Changes – Flector Patch (diclofenac epolamine) 1.3% topical patch Voltaren Gel (diclofenac sodium) 1 % topical gel |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – OxyContin (oxycodone hydrochloride) controlled-release tablets |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes – DepoDur (morphine sulfate extended-release) liposome injection |
DRUG CAUTIONARY NOTICE |
| 10.30.09 |
Drug Safety Labeling Changes –
Tramadol hydrochloride tablets:
- Ultracet (tramadol HCl/acetaminophen) tablets
- Ultram (tramadol hydrochloride) tablets
|
DRUG CAUTIONARY NOTICE |
| 10.26.09 |
Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials Recall |
DRUG CAUTIONARY NOTICE |
| 10.8.08 |
Heparin: Change in Reference Standard – The change will result in 10% reduction in the potency of the heparin marketed in the U.S. |
DRUG CAUTIONARY NOTICE |
| 9.28.09 |
Medtronic Intrathecal Catheters and Revision Kits --
Class I Recall Due to Possibility of Obstruction or Disruption of Therapy |
DEVICE WARNING |
| 9.17.09 |
Promethazine Hydrochloride Injection ‐ Boxed Warning Describing Severe Tissue Injury, Including Gangrene, After IV Administration of Drug |
DRUG CAUTIONARY NOTICE |
| 9.12.09 |
Drug Safety Labeling Changes – Wellbutrin (bupropion hydrochloride) Tablets and Sustained‐Release Tablets |
DRUG CAUTIONARY NOTICE |
| 8.10.09 |
Colchicine (marketed as Colcrys) - Two Previously Uncharacterized Safety Concerns Associated With the Use of Colchicine |
DRUG CAUTIONARY NOTICE |
| 7.7.09 |
Arthroscopic Shavers: Reports Describing Instances of Tissue Remaining Within Arthroscopic Shavers Even After Cleaning Process Completed |
DEVICE CAUTIONARY NOTICE |
| 7.7.09 |
Propoxyphene-Containing Products: FDA Taking Actions to Reduce Risk of Overdose Because of Data Linking Propoxyphene and Fatal Overdoses |
DRUG CAUTIONARY NOTICE |